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SOFTEC Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection…
EUDAMEDClass IVD General (EU MDR)
Ref ZT-HPV-01-100Model TUBE
Identity
- Trade Name
- SOFTEC Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit EUDAMED
- Device Name
- Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit EUDAMED
- Model / Reference
- TUBE EUDAMEDZT-HPV-01-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616596 EUDAMED
- Basic UDI-DI
- B-08697962616596 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SOFTEC Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection… by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08697962616596 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000046897
Sources (1)
- EUDAMED 33601e76-47fb-4772-931d-4f9e19507ad1 61 fields · synced Jun 19, 2026